Drug Importation Brings on Unnecessary Risk and Harmful Unknowns

Today, the House Energy and Commerce Committee held a full committee markup on the FDA User Fee Reauthorization Act of 2017. Several measures were added as Amendments and voted on in today’s hearing.

One measure could allow the importation of pharmaceuticals from Canada—claiming it would allow Americans to gain access to much-needed drugs at lower prices.

While well-intentioned, this measure brings into serious question not only the role of international pharmaceuticals in the U.S. health care market, but also the critical safeguards we place within our health care system.

WASHINGTON, DC - MARCH 08: U.S. Reps. Elijah Cummings (D-MD) (R) and Peter Welch (D-VT) speak to the media after a meeting with U.S. President Donald Trump at the White House, on March 8, 2017 in Washington, DC. Cummings, the top Democrat on the House committee on Oversight and Government Reform, had earlier said in a statement that their meeting was over prescription drug prices. (Photo by Mark Wilson/Getty Images)

In practice, this new measure seeks to undercut the Medicare Modernization Act passed in 2003, which requires the Secretary of Health and Human Services to critically assess any potential importation of drugs from Canada. However, the new bill seems to miss that prescription drug importation must only be allowed if the imports pose no risk to public health and would truly generate cost-savings for Americans.

Since the passage of the Medicare Modernization Act, no Secretary has been able to confidently satisfy these requirements.

Clearly, the requirements for importation are based on a very high standard for ensuring patient safety.

The United States sets the global standard for pharmaceutical development and regulation. We prevent the very problems that drug importation would feasibly allow. Importing medicines from countries that do not hold these quality standards could contaminate our pharmaceutical supply.

Drugs that come from Canada are oftentimes produced in other countries with lax regulatory systems, including China, and even imports that are allegedly “Canadian” may have come from anywhere, regardless of what a website indicates.

The indeterminable production and shipping conditions of these drugs brings about great risks. While one in ten medicines worldwide are counterfeit, the United States high standards prevent those drugs from seeping into our marketplace. In 2014, 96% of internet drug outlets were found to be operating outside of compliance with U.S. pharmacy laws.

As our country faces a debilitating opioid epidemic, the introduction of new medication with unknown properties would only exacerbate our pressing health crisis. This importation measure heightens the risk of importing counterfeit opioids invading our domestic market, which only increases the sheer volume of opioids available and holds the potential to worsen our nation’s pervasive drug crisis.

Rather than bring in high-risk, cheaper drugs from Canada, or possibly from Chinese sources, the federal government should look to how drug prices can stabilize within our country’s own health care system. As always, health care policies must prioritize the safety and wellness of patients in need without jeopardizing the health of our country or the effectiveness of our health care system.

(DISCLOSURE: From August 2015 to October 2017, I served on the board of the Rosenthal Center for Addiction Studies, and conducted marketing research for them. The opinions in this article are my own.)